1. Field of the Invention
The present invention relates to an electrosurgical generator with an adaptive power control, and more particularly to an electrosurgical generator that controls the output power in a manner that causes impedance of tissue to rise and fall cyclically until the tissue is completely desiccated.
2. Background of the Disclosure
Electrosurgical generators are used by surgeons to cut and coagulate tissue of a patient. High frequency electrical power is produced by the electrosurgical generator and applied to the surgical site by an electrosurgical tool. Monopolar and bipolar configurations are common in electrosurgical procedures.
Electrosurgical generators are typically comprised of power supply circuits, front panel interface circuits, and RF output stage circuits. Many electrical designs for electrosurgical generators are known in the field. In certain electrosurgical generator designs, the RE output stage can be adjusted to control the RMS output power. The methods of controlling the RF output stage may comprise changing the duty cycle, or changing the amplitude of the driving signal to the RF output stage. The method of controlling the RF output stage is described herein as changing an input to the RF output stage.
Electrosurgical techniques have been used to seal small diameter blood vessels and vascular bundles. Another application of electrosurgical energy is tissue welding. In this application, two layers of tissue are grasped and clamped together while electrosurgical power is applied. The two layers are thereby welded together. Tissue welding is similar to vessel sealing, except that a vessel or duct is not necessarily sealed in this process. For example, tissue welding may be used instead of staples for surgical anastomosis, Electrosurgical power has a desiccating effect on tissue during tissue welding or vessel sealing. As used herein, the term “electrosurgical desiccation” is meant to encompass any tissue desiccation procedure, including standard electrosurgical coagulation, desiccation, vessel sealing, and tissue welding.
One of the problems associated with electrosurgical desiccation is undesirable tissue damage due to thermal effects. The tissue at the operative site is heated by the electrosurgical current. Healthy tissue adjacent to the operative site can become thermally damaged if too much heat is allowed to build up at the operative site. The heat may conduct to the adjacent tissue and cause a large region of tissue necrosis. This is known as thermal spread. The problem of thermal spread becomes important when electrosurgical tools are used in close proximity to delicate anatomical structures. Therefore, an electrosurgical generator that reduced the possibility of thermal spread would offer a better opportunity for a successful surgical outcome.
Another problem that is associated with electrosurgical desiccation is a buildup of eschar on the surgical tool, Eschar is a deposit on an electrosurgical tool that is created from tissue that is desiccated and then charred by heat. The surgical tools win often lose effectiveness when they are coated with eschar. The buildup of eschar could be reduced when less heat is developed at the operative site.
Practitioners have known that a measurement of electrical impedance of tissue is a good indication of the state of desiccation of the tissue. Several commercially available electrosurgical generators can automatically terminate output power based on a measurement of impedance. Several methods for determining the optimal point of desiccation are known in the field. One method sets a threshold impedance, and terminates power once the measured impedance of the tissue crosses the threshold. Another method terminates power based on dynamic variations in the impedance.
A discussion of the dynamic variations of impedance of tissue can be found in the article, Vallfors and Bergdahl “Automatically Controlled Bipolar Electrocoagulation,” Neurosurgical Review, 7:2-3, pp. 187-190, 1984. FIG. 2 in the Vallfors article shows impedance as a function of time during heating of tissue. Valfors reports that the impedance value of tissue proved to be close to minimal at the moment of coagulation. Based on this observation, Vallfors suggests a micro-computer technique for monitoring the minimum impedance and subsequently terminating output power to avoid charring the tissue.
A second article by Bergdahl and Vallfors, “Studies on Coagulation and the Development of an Automatic Computerized Bipolar Coagulator,” Journal of Neurosurgery, 75:1, 148-151, July 1991, discusses the impedance behavior of tissue and its application to electrosurgical vessel sealing. The Bergdahl article reported that the impedance had a minimum value at the moment of coagulation. The Bergdahl article also reported that it was not possible to coagulate safely arteries with a diameter larger than 2 to 2.5 millimeters. The present invention helps to overcome this limitation by enabling electrosurgical vessel seating of larger diameter vessels.
U.S. Pat. No. 5,540,684 discloses a method and apparatus for electrosurgically treating tissue in a manner similar to the disclosures of Vallfors and Bergdahl. The '684 patent addresses the problem associated with turning off the RF output automatically after the tissue impedance has reached a minimum value. A storage device records maximum and minimum impedance values, and an algorithm computes an optimal time for terminating output power.
U.S. Pat. No. 4,191,188 discloses a variable crest factor electrosurgical generator. The crest factor is disclosed to be associated with the coagulation effectiveness of the electrosurgical waveform.
U.S. Pat. No. 5,472,443 discloses the variation of tissue impedance with temperature. The impedance of tissue is shown to fall, and then subsequently rise as the temperature is increased. The '443 patent shows a relatively lower temperature region (Region A in
It would be desirable to have an electrosurgical generator that produced a clinically effective output and, in addition, reduced the amount of heat and thermal spread at the operative site. It would also be desirable to have an electrosurgical generator that produced a better quality seal for vessel sealing and tissue welding operations. It would also be desirable to have an electrosurgical generator that desiccated tissue by applying a minimal amount of electrosurgical energy.
According to one aspect of the present disclosure an electrosurgical generator for applying output power to tissue is disclosed. The electrosurgical generator includes a tissue impedance measurement circuit configured to measure tissue impedance and a controller coupled to the tissue impedance measurement circuit. The controller is adapted to cycle output power from the electrosurgical generator to cause a cycling of the tissue impedance by applying the output power to tissue and then adjusting the output power to at least one of a lower output value and termination of output power. The controller is further adapted to re-apply the output power to tissue if tissue impedance does not indicate tissue desiccation and to terminate output power when the measured tissue impedance indicates tissue desiccation.
According to another aspect of the present disclosure, an electrosurgical generator for treating tissue by applying energy is disclosed. The electrosurgical generator includes a desiccation detector configured to determine completeness of tissue desiccation and a controller coupled to the desiccation detector. The controller is adapted to cycle output power to cause a cycling of tissue impedance in response to the degree of tissue desiccation. The controller is further adapted to re-apply the output power to tissue if the desiccation detector does not indicate tissue desiccation.
A method for applying electrosurgical energy to tissue to treat tissue is also contemplated by the present disclosure. The method includes the steps of: a) cycling output power from an electrosurgical generator to cause a cycling of tissue impedance by applying output power to tissue and then adjusting output power to at least one of a lower output value and termination of output power and re-applying output power to tissue if tissue impedance does not indicate tissue desiccation. The method also includes the steps of c) allowing the tissue impedance to fall to a predetermined minimum value and then raising the output power to cause an increase in tissue impedance and d) repeating steps b and c until tissue impedance at least reaches a predetermined value that corresponds to tissue desiccation.
Particular embodiments of the present disclosure will be described herein below with reference to the accompanying drawings. In the following description, well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail.
a) is a sample of experimental data for a standard vessel sealing operation, showing output power as function of time.
b) is a sample of experimental data for a standard vessel sealing operation, showing load impedance as a function of time.
c) is a sample of experimental data for a standard vessel sealing operation, showing output current as a function of time.
d) is a sample of experimental data for a standard vessel sealing operation, showing output voltage as a function of time.
a) is a sample of experimental data for an adaptive power control generator, showing output power as fiction of time.
b) is a sample of experimental data for an adaptive power control generator, showing load impedance as a function of time.
c) is a sample of experimental data for an adaptive power control generator, showing output current as a function of time.
d) is a sample of experimental data for an adaptive power control generator, showing output voltage as a function of time.
a) is a representation of a power curve for a standard electrosurgical generator.
b) is a representation of an adaptive oscillatory power curve.
The present invention discloses an adaptive, oscillatory power curve which is able to reduce thermal spread in each of these areas by applying power in a cyclical fashion, rather than continuously. During the periods of reduced power application, thermal energy is allowed to dissipate which reduces direct thermal conduction. Also, the steam exits the weld site in smaller bursts, which produces less thermal damage than one large burst. Finally, the impedance between the jaws of the electrosurgical instrument is kept low, which allows current to flow more directly between the jaws.
Charring is also reduced. High voltages contribute to tissue charring, which is why it is preferable to limit the output voltage of the electrosurgical generator to 120 volts, and to periodically reduce it to a lower value during power cycling. A relatively low voltage is also important because it prevents electrical sparks, or arcs, from passing through the tissue and burning small holes in the newly sealed, or welded, tissue.
The transparency, or clarity, at the weld site has been identified as an indicator of successful seal completion. It also gives the surgeon visual feedback as to whether the seal is a success. Preliminary findings indicate that this method may also increase weld site transparency. The reason for this is unknown, but it seems reasonable that reduced charring will allow the weld site to remain more transparent.
Referring to
The difference signal C may be input to a controller 12 that generates a control signal D. The control signal D adjusts or terminates the output power of the electrosurgical generator by changing the state of the RF. Output Stage 13. The controller 12 may be comprised of an algorithm in a microprocessor that determines the conditions for power termination based on the amplitude of the control signal. Alternatively and equivalently, the controller 12 may be connected directly to the measured tissue impedance B to terminate power based on the amplitude of the measured tissue impedance B. The controller 12 may be comprised of any combination of proportional integral, and derivative control laws that are known to control system engineers. Other types of control laws, such as “bang-bang” control laws, are effective equivalents.
In one embodiment, the command input signal A has a cyclic pattern, for example a sine wave or a square wave. The cyclic nature of the command input signal A causes the control system 10 to regulate the output power in a cyclic manner to achieve beneficial surgical effects. The controller 12 monitors the difference signal C to determine the response of the output power E. In one embodiment, when the difference signal C is large, and the impedance measurement B is above threshold, then the controller 12 terminates the output power E.
The control signal D is preferably connected to an R.F. Output Stage 13. The control signal D preferably changes a driving voltage in the R.F. output stage to thereby change the RMS output power from the electrosurgical generator, shown as line E in
The generator R.F. Output Stage 13 causes the electrosurgical generator to output a power level E to the tissue 14 of the patient. The tissue 14 becomes desiccated, thereby changing the electrical impedance, shown by F in
Electrical engineers will recognize that output power from an electrosurgical generator can be adjusted in several ways. For example, the amplitude of the output power can be adjusted. In another example, the output power can be adjusted by changing the duty cycle or the crest factor. The change or adjustment in output power, as used herein is meant to refer any change or adjustment in the root mean square (RMS) value of the output power of the electrosurgical generator.
In operation, the control system 10 is designed to cycle the tissue impedance F for preferably several cycles in order to achieve beneficial effects. Thus, the command input signal A is a cyclically varying signal such as a sine wave. An example of cyclical impedance behavior of tissue is shown in
The present invention discloses an adaptive, oscillatory power curve which is able to reduce thermal spread in each of these areas by applying power in a cyclical fashion, rather than continuously. During the periods of reduced power application, thermal energy is allowed to dissipate which reduces direct thermal conduction. Also, the steam exits the weld site in smaller bursts, which produces less thermal damage than one large burst. Finally, the impedance between the jaws of the electrosurgical instrument is kept low, which allows current to flow more directly between the jaws.
Charring is thought to be reduced by the present invention. High voltages contribute to tissue charring, which is why it is preferable to limit the output voltage of the electrosurgical generator to 120 volts, and to periodically reduce it to a lower value during power cycling. A relatively low voltage is also important because it prevents electrical sparks, or arcs, from passing through the tissue and burning small holes in the newly sealed, or welded, tissue.
The transparency, or clarity, at the weld site has been identified as an indicator of successful seal completion. It also gives the surgeon visual feedback as to whether the seal is a success. Preliminary findings indicate that this method may also increase weld site transparency. The reason for this is unknown, but it seems reasonable that reduced charring will allow the weld site to remain more transparent.
A plot of output power vs. load impedance is called a “power curve.” A representation of a standard power curve is shown in
The present invention is related to an electrosurgical generator having an adaptive oscillatory power curve as shown in
The first part of the adaptive oscillatory power curve, shown at the line segment I in
As a consequence of the lower voltage limit, the output power drops to the level indicated by H in
The behavior shown in
It is theorized by the inventor that the following phenomena occur. The initial high output power initiates boiling in the tissues. The subsequent low output power is insufficient to maintain boiling, and hence boiling in the tissue stops. After boiling stops, if the tissue is not completely desiccated then the impedance will fall to a lower value. Next, the low impedance allows output power to increase, which re-heats the tissue to the point of boiling. The voltage is also pulled higher during the process, and remains so until the power curve can sense the onset of boiling, and lower the voltage, preferably back to 50 volts. The process continues until the tissue is fully desiccated. An oscillation is one cycle of high output power followed by low output power.
a) through 2(d) show experimental results on tissue samples using a standard power curve.
Output voltage and output current show a cyclic behavior in the adaptive oscillatory power curve. The cyclic behavior is absent in the standard power curve.
In one embodiment of the adaptive oscillatory power curve, the generator temporarily lowers the output voltage limit to 50 volts whenever the output voltage reaches 120 volts. This causes a reduction in output power, and if the tissue is not completely desiccated, a corresponding significant reduction in tissue impedance. After the reduction in tissue impedance, the output voltage limit is reset to 120 volts, allowing a rise in output power. This reduction and subsequent rise in output power constitutes a cycle.
Designers of electrosurgical generators have found that impedance is a good indicator of the desiccation state of the tissue. However, skilled artisans will recognize that it may not be necessary to compute an exact value for impedance. An electrical measurement that is proportional to the tissue impedance can be used as a functional equivalent. In one embodiment, the control system can properly create the adaptive oscillatory power curve based on measurements of time, and output voltage.
Table 1 shows a comparison between two sets of tests which compare a standard power curve with an adaptive oscillatory power curve. Test 1 indicates use of the standard power curve, while Test 2 indicates the use of the adaptive oscillatory power curve. Size indicates the vessel diameter in millimeters, burst pressures are measured in p.s.i., sticking, charring, and clarity are subjective measures ranked from 0 to 3, (where 0 represents a low value for sticking and charring, and 0 represents a poor value for clarity), and ts indicates thermal spread, measured in millimeters.
TABLE 1 Comparison of Standard Power Curve with Adaptive Power Curve Test # samples size bp stick charring clarity ts 1 (mean) 19 2.57 17.26 0.63 1.11 1.89 2.11 1 (SD) 1.35 1.04 0.76 0.81 1.29 0.74 1 (min) 1 12.96 1 (max) 6 17.50 2 (mean) 20 2.55 17.39 0.80 0.60 1.95 1.65 2 (SD) 1.36 0.44 1.06 0.60 1.36 0.81 2 (min) 1 15.52 2 (max) 5 17.50
Table 1 illustrates that the adaptive oscillatory power curve (Test 2) has several advantages over the standard power curve (Test 1). Most notable is the lower amount of thermal spread: a mean value of 2.1 mm for the standard power curve, and 1.65 mm for the adaptive oscillatory power curve. The subjective measures for sticking, charring and clarity of the weld show that the adaptive oscillatory power curve offer improvements over the standard power curve.
In general, the invention is an electrosurgical generator for treating tissue, wherein the electrosurgical generator comprises a circuit for generating a measurement of the load impedance, and an output power controller having means for inducing multiple oscillations of the load impedance in response to the measurement. The load impedance refers to the impedance of the tissue being treated by the electrosurgical generator. The circuit for generating a measurement of the load impedance can be analog or digital, and typically requires an output voltage sensor and an output current sensor. The output voltage is divided by the output current to compute a measurement of load impedance.
The means for inducing multiple oscillations of the load impedance preferably comprises a control system which can selectively control the output voltage to cause appropriate oscillations of the output power. In many electrosurgical generators, an output power control circuit has an adjustable voltage supply connected to the primary side of an isolation transformer. The secondary winding of the transformer is connected to an output resonant circuit. The voltage supply has an adjuster for changing the voltage to the transformer, and thereby changing the output voltage of the electrosurgical generator. A digital signal may be used to control the voltage supply.
The means for inducing multiple oscillations preferably comprise a feedback control system, where the feedback is a measurement of the load impedance. The control system preferably includes an algorithm in a microprocessor. The algorithm in the microprocessor can monitor the load impedance and determine how the load impedance is responding to a change in the output power.
In the preferred embodiment, the control system sets an output voltage limit of 120 volts RMS, and then controls the output power to a user desired setting, for example 100 watts. When the impedance is relatively low, a high current will combine with an output voltage of less than 120 volts to yield the desired power of 100 watts. As the impedance rises, the output current will fall, and the output voltage will be increased by the circuit to maintain the desired output power. When the voltage limit of 120 volts is reached, the control system will automatically lower the output voltage to a low value, preferably 50 volts. This effectively lowers the output power. If the tissue is not completely desiccated, the lower output power will cause the impedance to drop significantly. Once a local impedance minimum is detected, or after a set period of time, the output voltage limit is reset to 120 volts by the control system, and the cycle repeats. It has been found through experimentation that the oscillations of the load impedance will occur in the frequency range of one to twenty hertz, and this range has been referred to herein as the thermal bandwidth. In one embodiment, the control system terminates the output power after a set period of time which was three seconds. Alternatively, the control system can terminate power when the impedance reaches a threshold of 2000 ohms. Another alternative is to terminate output power when the measurement of impedance indicates that the impedance does not substantially fall in response to a drop in the output power.
The present invention is applicable to any form of electrosurgical coagulation. The benefits of the present invention, including reduced thermal spread, less eschar buildup, and improved desiccation, can be applied to both monopolar and bipolar electrosurgical generator outputs. While a particular preferred embodiment has been illustrated and described, the scope of protection sought is in the claims that follow.
This application is a continuation of U.S. patent application Ser. No. 10/434,019, filed on May 8, 2003, which is a reissue of U.S. patent application Ser. No. 09/209,323, now U.S. Pat. No. 6,228,080, filed on Dec. 11, 1998, which is a continuation of U.S. patent application Ser. No. 08/838,548, filed on Apr. 9, 1997, now U.S. Pat. No. 6,033,399, the contents of which are incorporated herein by reference.
Number | Date | Country | |
---|---|---|---|
Parent | 10434019 | May 2003 | US |
Child | 12136551 | US | |
Parent | 09209323 | Dec 1998 | US |
Child | 10434019 | US | |
Parent | 08838548 | Apr 1997 | US |
Child | 09209323 | US |